U.S. DRUG ENFORCEMENTADMINISTRATION

September 13, 2019Health Care Compliance Association

Minneapolis, Minnesota

William Stockmann Diversion Program Manager

Omaha Field Division

The following presentation was accompanied by an oral presentation on September 13, 2019, and does not purport to establish legal standards that are not contained in statutes, regulations, or other competent law. Statements contained in this presentation that are not embodied in the law are not binding on DEA. Summaries of statutory and regulatory provisions that are summarized in this presentation do not purport to state the full extent of the statutory and regulatory requirements of the cited statutes and regulations. I have no financial relationship to disclose.or any other DEA Registrant.

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Recognize some controlled substance prescription red flags. Discuss the requirements of a prescription. Reporting requirements for a theft or loss. Understand the pharmacist corresponding responsibility. Understand the Administrative, Civil and Criminal Penalties. Discuss current drug trends. Recognize the potential avenues for diversion. Discuss physical and electronic security for controlled

substances.Where to find DEA regulations and information.

LEARNING OBJECTIVES

PRESCRIPTION - RED FLAGS

RED FLAGS

Patterns of Prescribing• If it’s the same drug • If it’s the same quantity• If it’s the same combinations

The Trinity EqualsAn Opioid

A BenzodiazepineCarisoprodol *Soma

An often sought out combination of drugs – A dangerous cocktail

THE TRINITYHydrocodone

Carisoprodol – SomaAlprazolam

RED FLAGS

Cash Payments• Always pays cash• Has insurance but pays cash

The Unknown• Practitioner not known• Patient not known• Patient not from your town

RED FLAGS

Patients asking for specific Drugs• No generics• By manufacturer

Combinations of abused DrugsMasking with other substances

Patient may not fill all the “other”prescribed items

RED FLAGS

Patients located at the same address, not family members

Refills requested before the prescription should have run out

PURPOSE OF ISSUE OF PRESCRIPTION

PURPOSE OF ISSUE OF PRESCRIPTION

Title 21 Code of Federal Regulations § 1306.04

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but….

PHARMACIST CORRESPONDINGRESPONSIBILITY

Title 21 Code of Federal Regulations § 1306.04

a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

PRACTITIONER - PHARMACIST

EQUAL IN THE RESPONSIBILITY

MANNER OF ISSUANCE OFPRESCRIPTION

(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.

Title 21 Code of Federal Regulations § 1306.05

DEA DIVERSION WEB-SITE

DEA DIVERSION WEB-SITE

DEADiversion.usdoj.gov

DEA DIVERSION WEB-SITE

Link to verify a Practitioners DEA Registration

DEA 222 Order Forms Re-Order

DEADiversion.usdoj.gov

DEA REGISTRANT POPULATION

DEA Registrant Population as of August 2019

RETAIL LEVEL • Practitioner 1,256,651 • Mid-Level Practitioner 387,693• Retail Pharmacy 71,120• Hospital Clinic 18,413• Teaching Institution 262

WHOLESALE LEVEL • Researcher 12,071• Analytical Lab 1,531• NTP 1,748• Distributor 925• Manufacturer 580• Exporter 262• Importer 250• Reverse Distributor 69

TOTAL REGISTRANT POPULATION 1,846,284

DIVERSION AVENUES

Diversion Potential changes on many factorsBusiness Activity – Supply - Access

Hospital/Clinic Retail Pharmacy Distributor

Physicians Office Analytical Lab Manufacturer

Physical Security Protection deployed

CageVault

Safe Locked CabinetDispersed amongst other stock

Physical and Electronic Security Protection deployed

Avenues for Diversion

Armed Robberies Fake or not legitimate prescriptions

The Largest Avenue for DiversionPharmacies

Pharmacists, Pharmacy Technicians, Employees who have access to the

Pharmacy…

Burglaries

• Overrides – Cancel Orders • Sharing of pass codes • Inventory of ADS machines not completed• Training on pass codes – Changing of pass codes• Failure to completely empty for servicing

Why is it a Diversion Potential

Hospital Diversion Potential

– Criminal Investigation –

Nurse in ICU admits to taking Fentanyl from the Pyxis machine and replacing the Fentanyl with sterile solution.

She then cancelled the request when returning the Fentanyl to the Pyxis machine.

Factors in Reporting a Theft or Loss

• The actual quantity of controlled substances lost in relation to the type of business;

• The specific controlled substances lost;

• Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;

• A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,

Reporting the Theft or Loss On-LineNEW - DEA Form 106 / 107

DEADiversion.usdoj.gov

Reporting the Theft or Loss On-LineDEA Form 106 / 107

DEADiversion.usdoj.gov

Reporting the Theft or Loss On-LineDEA Form 106 / 107

DEADiversion.usdoj.gov

Reporting the Theft or Loss On-LineDEA Form 106 / 107

DEADiversion.usdoj.gov

• Break-in/Burglary• Employee Theft (or Suspected)• Hijacking of Transport Vehicle• Packaging Discrepancy• Robbery• Customer Theft (or Non Employee)• Loss in Transit• Disaster (fire, weather, etc.)

Theft/Loss Types:

Penalties for Violations

Administrative, Civil & Criminal Penalties

Criminal Charges –Federal or State Law

Civil Fines – Federal

Administrative Actions –RevocationRestrictionsLetter of AdmonitionMemorandum of Agreement

$$$ Per Violation

Doctor convicted of murder for patients drug overdoses gets 30 years to life in prison

In 2016 Dr. Hsiu-Ying “Lisa” Tseng was sentenced to 30 years to life in prison for the murders of three of her patients who fatally overdosed, making Tseng the first doctor to be convicted of murder in the United States for overprescribing drugs. On appeal.

Associated Press | Apr 13, 2018 | 4:30 AM

A pharmacist convicted of taking part in a long-running conspiracy to illegally distribute large quantities of oxycodone and other drugs from two pharmacies he owned is now headed to prison.

Federal prosecutors say Michael Ludwikowski received a 15-year sentence Thursday. He had been found guilty of six counts last August, including conspiracy and maintaining drug-involved premises.

Prosecutors say the 46-year-old Medford man and an employee at his two pharmacies in Medford distributed the drugs to addicts and others who presented phony prescriptions. The employee pleaded guilty December 2016.

Pharmacist sentenced for conspiracy to distribute oxycodone

Abington hospital to pay $510,000 in pharmacist's theft of 35,000 pills, including

oxycodone Montgomery County Hospital will pay more than half a million dollars to resolve allegations stemming from an employee's theft of controlled substances.

Abington Hospital agreed to pay $510,000 to settle allegations that its controls and practices enabled a staff pharmacist to take prescription medications for illegal use, according to the U.S. Attorneys Office in Philadelphia.

January 09, 2017

The pharmacist pleaded guilty to possession with the intent to distribute oxycodone, she was sentenced to six years in prison and three years of supervised release.

Civil Monetary Penalties Inflation Adjustment - 2016

(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II of this chapter;

Civil PenaltiesRecord Keeping Violations

Date Received

Failed to document date received -shipped on Official Order Form

$14,502.00 per line

Civil Fines can add up quickly on record keeping violations!

Drug Abuse Education

Would it benefit your business to educate your employees and their families

Investing in education benefits the employee and the business

Employees are informedwith the direction of the business relating to drug use - abuse

Positive re-enforcement for the employee that the company is engaged with current events – the opioid epidemic

The company places employees on notice with education and policy

What is your company doing with your employees

Do you have a zero tolerance policy on drug abuse and theft

Do you provide drug abuse & prevention education

Or

Current Trends

Clandestine Laboratory Oxycodone Counterfeit & Real Tablets

Xanax Counterfeit and Real Tablets

Photo depicts fatal amounts of each drug

As a matter of reference it has been determined that it would only take 2-3 milligrams of fentanyl to induce respiratory depression

Heroin, Fentanyl and Carfentanil

Potency Level of Fentanyl

Lab Equipment & Supplies

Distributed by U.S. Mail

Tablets & Cash

Opioids in the United States (CDC)

• In 2017 – 70,237 drug overdose deaths in the U.S.– Over 192 deaths a day

• 1,350 a week• 5,853 a month

• Opioids were involved in 47,600 of those deaths (≈68%).

2017 - CDC

2017 - CDC

2017 – CDC

EXAM Time

Question…?

61

1. A pharmacist is obligated to fill a prescription that is presented by a patient or is demanded to be filled by a practitioner.

A. TrueB. False

U.S. Drug Enforcement AdministrationDiversion Control Division

Question…?

62

3. What is the best safeguard to identify a patient who is doctor shopping?

A. Secure prescriptionsB. Routinely use the PDMPC. Conduct routine examinationsD. Never sign blank prescriptions

U.S. Drug Enforcement AdministrationDiversion Control Division

Questions…?

63

4. Diversion of controlled substances can be conducted by:

A. Staff membersB. PractitionersC. Patients D. All of the above

U.S. Drug Enforcement AdministrationDiversion Control Division

Questions

DEAContact Information

deadiversion.usdoj.gov

Minneapolis – St. Paul District OfficeDiversion Group 612-344-4143

Slide Number 1Slide Number 2Fair Use Act DisclaimerSlide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11Slide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17Slide Number 18Slide Number 19Slide Number 20Slide Number 21Slide Number 22Slide Number 23Slide Number 24Slide Number 25Avenues for DiversionThe Largest Avenue for Diversion�PharmaciesHospital Diversion Potential – Criminal Investigation –Slide Number 30Slide Number 31Factors in Reporting a Theft or LossReporting the Theft or Loss On-Line�NEW - DEA Form 106 / 107�Reporting the Theft or Loss On-Line�DEA Form 106 / 107�Reporting the Theft or Loss On-Line�DEA Form 106 / 107�Reporting the Theft or Loss On-Line�DEA Form 106 / 107�Penalties for Violations Administrative, Civil & Criminal Penalties Doctor convicted of murder for patients drug overdoses gets 30 years to life in prisonSlide Number 40Slide Number 41Civil Monetary Penalties Inflation Adjustment - 2016Civil Penalties�Record Keeping Violations Drug Abuse EducationSlide Number 45Slide Number 46Current TrendsSlide Number 48Xanax Counterfeit and Real TabletsSlide Number 50Slide Number 51Lab Equipment & SuppliesSlide Number 53Slide Number 54Slide Number 55Opioids in the United States (CDC)Slide Number 57Slide Number 58Slide Number 59EXAM TimeQuestion…?Question…?Questions…?QuestionsSlide Number 65